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510(k) K150329

elance Vital Signs Monitor, Central Monitor Software by Spacelabs Healthcare — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
February 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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